NCT04401410

Anti-SARS Cov-2 T Cell Infusions for COVID 19

BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.

Detailed description

The first part of this study is to identify the maximum tolerated dose (MTD) of allogeneic SARS-CoV2-specific T cells (SARS-CoVSTs) for patients with COVID19 with high risk of progression to mechanical ventilation. The 3 dose levels (DL) are: DL1: 1x10\^7 cells (flat dose) DL2: 2x10\^7 cells (flat dose) DL3: 4x10\^7 cells (flat dose) Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level. After the dose finding phase is complete and the MTD established, a randomized trial will be conducted. Patient will be randomized 1:1 using the permuted block method with a block size of 4 (2 in the treatment arm and 2 in the control arm) to receive treatment with SARS-CoVSTs or routine treatment per institutional standards. All enrolled patients will undergo the following evaluations: * Physical exam and history including height and weight * SARS-CoV-2 test * Blood tests * Chest X-ray or chest CT Scan if not already done in the past 48 hours. * A urine pregnancy test, when applicable Patients randomized to receive SARS-CoVSTs will be pre-medicated with Benadryl and Tylenol. The cells will be thawed and given through an intravenous line. Patients will be monitored for infusion side effects for up to 14 days or until infusion side effects have completely resolved, whichever is longer. Blood will be drawn before the infusion and then up to daily for 14 days or until the patient is discharged from the hospital. Optional blood samples will be drawn at 2, 3 and 6 months after infusion. Study participation will last 6 months after the date of infusion.

Conditions

• SARS-CoV 2
• Viral Infection
• COVID 19

Interventions

Type	Name	Description
BIOLOGICAL	Dose Finding Phase (MTD)	Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.
BIOLOGICAL	Partially HLA-matched SARS-CoVSTs	Infusion of SARS-CoVSTs at the MTD level as determined in the Dose Finding Phase
OTHER	Routine care (no SARS-CoVSTs)	Patients receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2020-05-26
• Last updated: 2022-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study